Glaxosmithkline to pay Vermont $2 million as part of largest healthcare fraud settlement in US history
Attorney General William H. Sorrell announced today that Vermont will receive approximately $2 million from pharmaceutical manufacturer GlaxoSmithKline (GSK) as part of the largest healthcare fraud settlement in US history.
Under the terms of the settlement, GSK will pay to the states and the federal government a total of $3 billion to resolve criminal and civil allegations that GSK unlawfully marketed certain drugs for uses for which the drugs were not approved by the Food and Drug Administration (FDA); made false representations regarding the safety and efficacy of certain drugs; offered kickbacks to medical professionals; and underpaid rebates for various drugs paid for by Medicaid and other federally-funded healthcare programs.
Specifically, the states and federal government alleged that, as far back as 1998, GSK engaged in the following activities:
- Marketing the depression drug Paxil for off-label uses, such as use by children and adolescents;
- Marketing the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages;
- Marketing the asthma drug Advair for off-label uses, including first-line use for asthma;
- Marketing the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions;
- Marketing the nausea drug Zofran for off-label uses, including pregnancy-related nausea;
- Making false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
- Offering kickbacks, including entertainment, cash, travel, and meals, to healthcare professionals to induce them to promote and prescribe Paxil, Wellbutrin, Advair, Lamictan, Zofran, the migraine drug Imitrex, the irritable bowel syndrome drug Lotronex, the asthma drug Flovent, and the shingles and herpes drug Valtrex; and
- Submitting incorrect pricing data for various drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.
In addition, as part of the settlement, GSK will plead guilty to federal criminal charges that it violated the federal Food, Drug, and Cosmetic Act (“FDCA”) by introducing certain drugs into interstate commerce without proper labeling, and failed to report clinical data regarding Avandia to the FDA. According to Attorney General Sorrell, this settlement is “further proof that Vermont will not tolerate marketing violations by the pharmaceutical industry, and will work closely with other states, whistleblowers, and the federal government to aggressively investigate reports of industry misconduct as they arise.”
Vermont Attorney General, July 2, 2012